BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIC PRO CLINICAL INFORMATION CENTER

    MDR report key: 2092187 · Received April 27, 2011

    Report

    Report Number
    2124823-2011-00048
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 27, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A SITE REPORTED A LOSS OF TELEMETRY MONITORING FOR 5 PTS FOR APPROX 2 HRS FOLLOWING A POWER OUTAGE. WHEN POWER WAS RESTORED THE CENTRAL MONITORING SYSTEM DID NOT RE-ESTABLISH COMMUNICATION WITH THE TELEMETRY MONITORING UNITS. NO ALTERNATE MONITORING WAS ESTABLISHED DURING THIS TIME. MONITORING WAS RESTORED BY COMPLETING A FULL POWER DOWN AND REBOOT OF THE SERVER. THERE WERE NO PT INJURIES REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIC PRO CLINICAL INFORMATION CENTER CENTRAL MONITORING SYSTEM DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1